FDA: All Contaminated Flu Vaccine Unusable

None of the more than 48 million flu vaccine (search) doses held up in a British manufacturing plant are fit for use in the U.S., dashing hopes that any of the doses can be salvaged to help fill a huge flu vaccine shortage in the U.S. supply, federal health officials confirmed Friday.

Acting FDA Commissioner Lester Crawford told reporters that inspections and testing in the Liverpool, England, plant owned by Chiron Corp. (search) showed that none of the flu vaccine can be shipped here for the 2004-2005 flu season.

"We believe all of the lots produced here, produced by that plant, are suspect at this point and we cannot allow them to be used in the United States in the interest of public health," Crawford says.

Flu Vaccine Fears Confirmed

Public health officials had held out little hope that any of the Chiron flu vaccine would prove safe for use. Friday's announcement confirms their fears that the U.S. will have only about half the flu vaccine needed to protect approximately 100 million persons thought to be at high risk if they catch the flu.

British regulators suspended Chiron's manufacturing license on Oct. 5, citing poor manufacturing practices and bacterial contamination in nine of 100 lots produced at the plant. More FDA inspections this week found that the contamination occurred during the process of filling flu vaccine vials, Crawford says.

The CDC reacted to the flu vaccine shortage by issuing updated vaccination guidelines (search) limiting recommended flu vaccines for persons over 65, babies between five and 23 months, those with underlying health conditions, caregivers of sick persons, and those who share a household with an infant. Women who will be pregnant during flu season and some health workers are also on the list.

The shortage has caused long lines for flu vaccines all over the country as well as reports of price gouging on the part of distributors and clinics.

The two senior members of House Committee on Government Reform called on the Federal Trade Commission Friday to launch an investigation into the widespread price gouging reports.

Flu Vaccine Redirected

CDC Director Julie M. Gerberding, MD, says the CDC plans to redirect some 4 million doses of vaccine made by Aventis Pasteur (search) to Veterans Administration hospitals, nursing homes, acute care hospitals and private doctors who care for young children.

Gerberding urged consumers to avoid standing in long lines waiting for a flu vaccine and instead to contact local and state health departments to find out when and where the vaccine would be available for high-risk persons.

"They are the ones in the best position to know who has the vaccine," she says.

Meanwhile, officials say they are trying to locate other foreign flu vaccine providers in an effort to find more flu vaccine for the U.S. market. It still remains unclear if or how U.S. authorities could clear flu vaccines out of their regulatory control for use in the U.S.

"Literally every known manufacturer of flu vaccine in the world is being contacted," Crawford says. "We do not want to create false hope, but we want to explore every option."

 

Reviewed by Michael W. Smith, MD

SOURCES: Lester Crawford, acting commissioner, FDA. Julie M. Gerberding, director, CDC.